Foreign Filer Report • Nov 13, 2023
Foreign Filer Report
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FORM 6-K
For the Month of November 2023
Commission File Number 001-35948
Kamada Ltd. (Translation of registrant's name into English)
2 Holzman Street Science Park, P.O. Box 4081 Rehovot 7670402 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
This Form 6-K is being incorporated by reference into the Registrant's Form S-8 Registration Statements, File Nos. 333-192720, 333-207933, 333-215983, 333-222891, 333-233267 and 333-265866.
| 99.1 | Kamada Reports Significant Increase in Sales and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance |
|---|---|
| 99.2 | Company's Presentation – November 2023 |
| 99.3 | Kamada Ltd's Consolidated Financial Statements as of September 30, 2023 (Unaudited) |
| 101.INS | Inline XBRL Instance Document. |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 13, 2023 KAMADA LTD.
By: /s/ Nir Livneh
Nir Livneh Vice President General Counsel and Corporate Secretary
| EXHIBIT NO. | DESCRIPTION |
|---|---|
| 99.1 | Kamada Reports Significant Increase in Sales and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance |
| 99.2 | Company's Presentation – November 2023 |
| 99.3 | Kamada Ltd's Consolidated Financial Statements as of September 30, 2023 (Unaudited) |
| 101.INS | Inline XBRL Instance Document. |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
Rehovot, Israel, and Hoboken, NJ – November 13, 2023 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced financial results for the three and nine months ended September 30, 2023.
"We are highly encouraged with our strong financial and operational momentum during the first nine months of the year," said Amir London, Kamada's Chief Executive Officer. "With total revenues of \$106.1 million, which represent year-over-year growth of 26%, and adjusted EBITDA of \$17.7 million, an increase of 67% as compared to the first nine months of 2022, we achieved the top- and bottom-line growth anticipated in our business in the first nine months of the year. We continue to effectively leverage our multiple growth drivers, including a significant increase in sales of our anti-rabies immunoglobulin product, KEDRAB® as well as the portfolio of the four FDA-approved immunoglobulins (CYTOGAM®, HEPAGAMB®, VARIZIG® and WINRHO® SDF), and our Israeli distribution business."
"We expect the momentum from the first nine months of the year to extend through the fourth quarter of 2023, with annual profitability to be further meaningfully enhanced as compared to last year. As such, we are reiterating our full-year 2023 revenue guidance of \$138 million to \$146 million and adjusted EBITDA of \$22 million to \$26 million; the mid-point of the range would represent profitability growth of approximately 35% over 2022," continued Mr. London.
"During the recent period we reported multiple achievements with CYTOGAM. Specifically, following recent FDA approval of the technology transfer process, CYTOGAM manufactured at our Israeli facility is now available for commercial sale in U.S., and new clinical data highlighting five-year real-world survival benefits of high risk CMV mismatch lung transplant patients receiving CYTOGAM were presented at IDWeek 2023. In addition, we continue to advance our pivotal phase 3 InnovAATe trial for Inhaled AAT and we recently received positive feedback from the independent Data and Safety Monitoring Board (DSMB) which recommended study continuation without modification for the sixth time since study initiation, based on encouraging safety data observed in the study to date," added Mr. London.
"Our future prospects were also recently further buoyed by the recent closing of our \$60 million private placement with FIMI Opportunity Funds. This strategic investment provides us with financial flexibility to pursue compelling business development opportunities, a process that we are currently engaged in," concluded Mr. London.

As of September 30, 2023, the Company had cash, cash equivalents, and short-term investments of \$52.6 million, as compared to \$34.3 million as of December 31, 2022. This includes the net proceeds of \$58.2 million received from the \$60 million financing closed during the third quarter. In addition, during the third quarter the Company made a \$17.4 million pay-down in full the outstanding balance of a bank loan. The Company is currently debt free.
Kamada continues to expect to generate fiscal year 2023 total revenues in the range of \$138 million to \$146 million. The Company also continues to anticipate generating adjusted EBITDA during 2023 in the range of \$22 million to \$26 million, the mid-point of the range would represent profitability growth of approximately 35% over 2022.
Kamada management will host an investment community conference call on Monday, November 13, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-877-407-0792 (from within the U.S.), 1 809-406-247 (from Israel), or 1 201-689- 8263 (International) and entering the conference identification number: 13741701. The call will also be webcast live on the Internet at:
https://viavid.webcasts.com/starthere.jsp?ei=1637192&tp_key=fd85a910fe.
We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure to assess our operational performance, for financial and operational decisionmaking, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes this non-IFRS financial measure are useful to investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company's core ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA and adjusted EBITDA are defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and derivatives instruments, net, plus depreciation and amortization expense, plus non-cash share-based compensation expenses and certain other costs.

Kamada Ltd. (the "Company") is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company's strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company's commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM®, KEDRAB®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years the Company added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D). In addition to the Company's commercial operation, it invests in research and development of new product candidates. The Company's leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company's lead shareholder, beneficially owning approximately 38% of the outstanding ordinary shares.
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: 1) continued ability to leverage growth drivers, 2) continuing the momentum of the first three quarters of 2023 in the last quarter and ability to enhance profitability, 3) reiteration of fiscal year 2023 guidance, 4) exploration of future business development prospects in the wake of the recent private placement proceeds, and 5) positive feedback relating to inhaled ATT clinical trial. Forward-looking statements are based on Kamada's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to the evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world, the impact of conflicts on market conditions and the general economic, industry and political conditions in Israel, the U.S. and globally, continuation of inbound and outbound international delivery routes, continued demand for Kamada's products, financial conditions of the Company's customer, suppliers and services providers, Kamada's ability to integrate the new product portfolio into its current product portfolio, Kamada's ability to grow the revenues of its new product portfolio, and leverage and expand its international distribution network, ability to reap the benefits of the acquisition of the plasma collection center, including the ability to open additional U.S. plasma centers, and acquisition of the FDA-approved plasma-derived hyperimmune commercial products, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial in new locations, unexpected results of clinical studies, Kamada's ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise, and other risks detailed in Kamada's filings with the U.S. Securities and Exchange Commission (the "SEC") including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC's website at www.sec.gov. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Chaime Orlev Chief Financial Officer [email protected]
Brian Ritchie LifeSci Advisors, LLC 212-915-2578 [email protected]
| As of September 30, 2023 2022 |
As of December 31, 2022 |
||||||
|---|---|---|---|---|---|---|---|
| Unaudited | Audited | ||||||
| Assets | |||||||
| Current Assets | |||||||
| Cash and cash equivalents | \$ | 52,603 | \$ | 31,252 | \$ | 34,258 | |
| Trade receivables, net | 25,107 | 23,997 | 27,252 | ||||
| Other accounts receivables | 1,648 | 6,884 | 8,710 | ||||
| Inventories | 73,795 | 73,029 | 68,785 | ||||
| Total Current Assets | 153,153 | 135,162 | 139,005 | ||||
| Non-Current Assets | |||||||
| Property, plant and equipment, net | 27,362 | 25,898 | 26,157 | ||||
| Right-of-use assets | 5,494 | 2,793 | 2,568 | ||||
| Intangible assets, Goodwill and other long-term assets | 142,501 | 148,620 | 147,072 | ||||
| Contract assets | 8,546 | 7,164 | 7,577 | ||||
| Total Non-Current Assets | 183,903 | 184,475 | 183,374 | ||||
| Total Assets | \$ | 337,056 | \$ | 319,637 | \$ | 322,379 | |
| Liabilities | |||||||
| Current Liabilities | |||||||
| Current maturities of bank loans | \$ | - | \$ | 4,444 | \$ | 4,444 | |
| Current maturities of lease liabilities | 1,138 | 1,004 | 1,016 | ||||
| Current maturities of other long term liabilities | 15,989 | 25,095 | 29,708 | ||||
| Trade payables | 12,812 | 30,619 | 32,917 | ||||
| Other accounts payables | 7,318 | 7,948 | 7,585 | ||||
| Deferred revenues | 15 | 40 | 35 | ||||
| Total Current Liabilities | 37,272 | 69,150 | 75,705 | ||||
| Non-Current Liabilities | |||||||
| Bank loans | - | 14,074 | 12,963 | ||||
| Lease liabilities | 4,717 | 2,414 | 2,177 | ||||
| Contingent consideration | 19,642 | 20,705 | 17,534 | ||||
| Other long-term liabilities | 36,477 | 39,915 | 37,308 | ||||
| Deferred revenues | - | 15 | - | ||||
| Employee benefit liabilities, net | 558 | 813 | 672 | ||||
| Total Non-Current Liabilities | 61,394 | 77,936 | 70,654 | ||||
| Shareholder's Equity | |||||||
| Ordinary shares | 15,020 | 11,732 | 11,734 | ||||
| Additional paid in capital net | 265,700 | 210,355 | 210,495 | ||||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | ||||
| Capital reserve from hedges | (98) | (257) | (88) | ||||
| Capital reserve from share-based payments | 6,198 | 5,427 | 5,505 | ||||
| Capital reserve from employee benefits | 318 | 212 | 348 | ||||
| Accumulated deficit | (45,258) | (51,428) | (48,484) | ||||
| Total Shareholder's Equity | 238,390 | 172,551 | 176,020 | ||||
| Total Liabilities and Shareholder's Equity | |||||||
| \$ | 337,056 | \$ | 319,637 | \$ | 322,379 |
| Nine months period ended September 30, |
Three months period ended September 30, 2023 2022 Unaudited |
Year ended December 31, |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 2022 |
2022 | |||||||||||
| Unaudited | Audited | |||||||||||
| Revenues from proprietary products | \$ | 86,437 | \$ | 67,198 | \$ | 31,436 | \$ | 25,580 | \$ | 102,598 | ||
| Revenues from distribution | 19,650 | 16,702 | 6,498 | 6,637 | 26,741 | |||||||
| Total revenues | 106,087 | 83,900 | 37,934 | 32,217 | 129,339 | |||||||
| Cost of revenues from proprietary products | 47,863 | 37,856 | 17,447 | 13,151 | 58,229 | |||||||
| Cost of revenues from distribution | 17,146 | 14,632 | 5,684 | 6,196 | 24,407 | |||||||
| Total cost of revenues | 65,009 | 52,488 | 23,131 | 19,347 | 82,636 | |||||||
| Gross profit | 41,078 | 31,412 | 14,803 | 12,870 | 46,703 | |||||||
| Research and development expenses | 10,694 | 10,181 | 3,180 | 3,118 | 13,172 | |||||||
| Selling and marketing expenses | 11,573 | 10,435 | 3,711 | 3,843 | 15,284 | |||||||
| General and administrative expenses | 10,603 | 9,481 | 3,701 | 3,165 | 12,803 | |||||||
| Other expenses | 920 | 801 | (157) | 182 | 912 | |||||||
| Operating income (loss) | 7,288 | 514 | 4,368 | 2,562 | 4,532 | |||||||
| Financial income | 92 | 32 | 67 | 29 | 91 | |||||||
| Income (expenses) in respect of currency exchange differences and | ||||||||||||
| derivatives instruments, net Financial Income (expense) in respect of contingent consideration and |
726 | 756 | 553 | 163 | 298 | |||||||
| other long- term liabilities. | (3,358) | (5,924) | (1,288) | (2,049) | (6,266) | |||||||
| Financial expenses | (1,343) | (583) | (404) | (211) | (914) | |||||||
| Income (expense) before tax on income | 3,405 | (5,205) | 3,296 | 494 | (2,259) | |||||||
| Taxes on income | 179 | 60 | 73 | 10 | 62 | |||||||
| Net income (loss) | \$ | 3,226 | \$ | (5,265) | \$ | 3,223 | \$ | 484 | \$ | (2,321) | ||
| Other comprehensive income (loss): | ||||||||||||
| Amounts that will be or that have been reclassified to profit or loss when specific conditions are met: |
||||||||||||
| Gain (loss) on cash flow hedges | (334) | (830) | (90) | (46) | (776) | |||||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges |
324 | 519 | 59 | 231 | 634 | |||||||
| Items that will not be reclassified to profit or loss in subsequent periods: |
||||||||||||
| Remeasurement gain (loss) from defined benefit plan | (30) | 361 | (106) | (59) | 497 | |||||||
| Total comprehensive income (loss) | \$ | 3,186 | \$ | (5,215) | \$ | 3,086 | \$ | 610 | \$ | (1,966) | ||
| Earnings per share attributable to equity holders of the Company: | ||||||||||||
| Basic net earnings per share Diluted net earnings per share |
\$ \$ |
0.07 0.06 |
\$ \$ |
(0.12) (0.12) |
\$ \$ |
0.07 0.06 |
\$ \$ |
0.01 0.01 |
\$ \$ |
(0.05) (0.05) |
||
| Nine months period Ended September, 30 |
Three months period Ended September, 30 |
Year Ended December 31, |
|||||
|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | |||
| Unaudited | Audited | ||||||
| Cash Flows from Operating Activities | |||||||
| Net income (loss) | \$ 3,226 |
\$ | (5,265) \$ |
3,223 | \$ 484 |
\$ (2,321) |
|
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
|||||||
| Adjustments to the profit or loss items: | |||||||
| Depreciation and impairment | 9,506 | 9,143 | 3,179 | 3,055 | 12,155 | ||
| Financial expenses (income), net | 3,883 | 5,719 | 1,072 | 2,068 | 6,791 | ||
| Cost of share-based payment | 941 | 935 | 312 | 366 | 1,153 | ||
| Taxes on income | 179 | 60 | 73 | 10 | 62 | ||
| Loss (gain) from sale of property and equipment | (5) | - | - | - | - | ||
| Change in employee benefit liabilities, net | (144) | (106) | (104) | (10) | (111) | ||
| 14,360 | 15,751 | 4,532 | 5,489 | 20,050 | |||
| Changes in asset and liability items: | |||||||
| Decrease (increase) in trade receivables, net | 2,078 | 10,744 | (618) | (6,358) | 7,603 | ||
| Decrease (increase) in other accounts receivables | 2,716 | 2,917 | 1,177 | 844 | (578) | ||
| Decrease (increase) in inventories | (5,011) | (5,606) | 6,441 | (8,509) | (1,361) | ||
| Decrease (increase) in deferred expenses | 2,763 | (2,596) | (279) | (2,112) | (1,340) | ||
| Increase (decrease) in trade payables | (18,617) | 5,895 | (13,181) | 13,738 | 7,055 | ||
| Increase (decrease) in other accounts payables | (359) | 566 | 49 | 2,083 | 290 | ||
| Decrease in deferred revenues | (20) | - | (23) | - | (20) | ||
| (16,450) | 11,920 | (6,434) | (314) | 11,649 | |||
| Cash received (paid) during the period for: | |||||||
| Interest paid | (1,149) | (550) | (405) | (170) | (853) | ||
| Interest received | 92 | 15 | 67 | 12 | 97 | ||
| Taxes paid | (174) | (27) | (62) | (9) | (36) | ||
| (1,231) | (562) | (400) | (167) | (792) | |||
| Net cash provided by (used in) operating activities | (95) \$ |
\$ 21,844 |
\$ | 921 | \$ 5,492 |
\$ 28,586 |
| Nine months period Ended September, 30 |
Three months period Ended September, 30 |
Year Ended December 31, |
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|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | |||||||
| Unaudited | Audited | ||||||||||
| U.S Dollars In thousands | |||||||||||
| Cash Flows from Investing Activities | |||||||||||
| Purchase of property and equipment and intangible assets | \$ | (3,876) | \$ | (2,807) | \$ | (1,729) | \$ | (1,616) | \$ | (3,784) | |
| Proceeds from sale of property and equipment | 6 | - | - | - | - | ||||||
| Net cash provided by (used in) investing activities | (3,870) | (2,807) | (1,729) | (1,616) | (3,784) | ||||||
| Cash Flows from Financing Activities | |||||||||||
| Proceeds from exercise of share base payments | 3 | 7 | - | 1 | 9 | ||||||
| Repayment of lease liabilities | (768) | (842) | (251) | (269) | (1,098) | ||||||
| Repayment of long-term loans | (17,407) | (1,517) | (15,185) | (1,116) | (2,628) | ||||||
| Repayment of other long-term liabilities | (17,500) | (4,120) | (11,500) | (877) | (5,626) | ||||||
| Proceeds from issuance of ordinary shares, net | 58,231 | - | 58,231 | - | - | ||||||
| Net cash provided by (used in) financing activities | 22,559 | (6,472) | 31,295 | (2,261) | (9,343) | ||||||
| Exchange differences on balances of cash and cash equivalent | (249) | 100 | 328 | (296) | 212 | ||||||
| Increase (decrease) in cash and cash equivalents | 18,345 | 12,665 | 30,815 | 1,319 | 15,671 | ||||||
| Cash and cash equivalents at the beginning of the period | 34,258 | 18,587 | 21,788 | 29,933 | 18,587 | ||||||
| Cash and cash equivalents at the end of the period | \$ | 52,603 | \$ | 31,252 | \$ | 52,603 | \$ | 31,252 | \$ | 34,258 | |
| Significant non-cash transactions | |||||||||||
| Right-of-use asset recognized with corresponding lease liability | \$ | 3,880 | \$ | 526 | \$ | 295 | \$ | 230 | \$ | 551 | |
| Purchase of property and equipment and Intangible assets | \$ | 681 | \$ | 134 | \$ | 681 | \$ | 134 | \$ | 618 |
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | ||||||
| In thousands | ||||||||||
| Net income | \$ 3,226 |
\$ | (5,265) | \$ | 3,223 | \$ | 484 | \$ | (2,321) | |
| Taxes on income | 179 | 60 | 73 | 10 | 62 | |||||
| Financial expense (income), net | 3,883 | 5,719 | 1,072 | 2,068 | 6,791 | |||||
| Depreciation and amortization expense | 9,506 | 9,143 | 3,179 | 3,055 | 12,155 | |||||
| Non-cash share-based compensation expenses | 941 | 935 | 312 | 366 | 1,153 | |||||
| Adjusted EBITDA | \$ 17,735 |
\$ | 10,592 | \$ | 7,859 | \$ | 5,983 | \$ | 17,840 |
INVESTORS MEETING NASDAQ & TASE: KMDA November 2023

This presentation is not intended to provide in should be noted that some products under development described herein have not been found safe or effective by any regulatory agency and are not approved for any use outside of clinical trials.
This presentation contains forward-looking statement beliefs and expectations of Kamada's management. Such statements include the 2023 financial guidane, success of the innel study, is benefits market size, sucess of the U.S. plann colection expaniti, and uncommiss and uncommiss and uncornities and uncornit cause Kanada's future results, performanty from the prospected results, performances or achievements expessed or implied by such fonward-looking statenents Innor on to could cause or continute to such and linned to risks relain to Kanada's alily to Kanada's alily to market aceptance of Kamada's commercial production the impact of any changes in regulation that could affect the pharmaceutical industy, the difficaly of predicting, obtaining U.S. Food and Drug Administration, European Medicary athrity approvals, the regulator environmental risk, changes in the worldwide pharmaceutical industry and other factors on oner the heading "Risk Factors" of Kanada's 2022 Annual Report on Form 20-F (fled on March 15, 2023) as well as in Kamada's recent Forms 6-K filed with the U.S. Securities and Exchange Commission.
This presentation includes cetain non-FRS financial information, which is not intended in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with IFRS. The non-FRS financial measures may not be comparable to, similary titled measures used by other companies with the requirement of the SEC regulation of these non-FRS financial measurs to the comparable IFRS measures is included in an appentation. Management uses these non-FRS financial measures for financial and operational decisionmaking and as a means to evaluate period comparisons. Management believes that these non-FRS financial supplemental information regarding Kamada's performance and liquidity.
Forward-looking statements speak only as of the are made, and Kamada undertakes no obligation to update any forward-hoking statement to reflect the impact of circumstances or events that arse after the date the reas nade, except as required by applices laws. You should not place undue reliance on any forward-looking statement and risks noted above, as well as the risks and uncertainties more fully discussed under the heading "fisk Factors" of Kanada's 2022 Anual Report on Form 20-F (filed on March 15, 2023) as well as in Kamada's recent Forms 6-K filed with the U.S. Securities and Exchange Commission.
Kamada is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions
The company is a leader in the specialty plasma-derived field focused on diseases of limited treatment alternatives
The company is advancing an innovative development pipeline targeting areas of significant unmet medical need




2023 represents annual guidance
Adjusted EBITDA is defined as net income, plus (i) tax expense, (ii) financial income (expense), net, (iii) depreciation
and amortization; and (v) non-cash share-based comp
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| das P | |
| Carred La |
[Hepatitis B Immune Globulin (Human)] Prevention of HBV recurrence following liver transplantation

[Varicella Zoster Immune Globulin (Human)] Post-exposure prophylaxis of varicella in high- risk patient groups

[Alpha1-Proteinase Inhibitor (Human)] Augmentation therapy for Alpha-1 Antitrypsin Deficiency (AATD)

[Rho(D) Immune Globulin (Human)] Treatment of immune thermobocytopunic purpura (ITP) & suppression of Rh isoimmunization (HDN)




STRATEGIC ENTRY INTO THE U.S. PLASMA COLLECTION MARKET 9 Kamada / November 2023

Kamada Plasma was established in Q1 2021 through the acquisition of an FDA-licensed plasma collection center in Texas, focusing on collecting hyperimmune plasma for specialty IgG's

10 Kamada / November 2023


Global, double-blind, randomized, placebo-controlled pivotal Phase 3 clinical trial to test the safety and efficacy of inhaled AAT in patients with AATD. Study design meet FDA and EMA's requirements

Prof. Benjamin Dekel currently serves as the Founder and Chief Scientist of RenoVate Biopharmaceuticals Ltd., as director at Sagol Center for Regenerative Medicine, Tel Aviversity; as Vice-Dean, School of Medicine, Tel Aviv University; Chief, Pediatic Nephrology and Pediatric Stem Cell Research Institute, Sheba Medical Center, as a member of the Higher Committee on Cell and Gene Therapy, Israel Ministry of Heath; and as a member of the Scientific Advisory Board, Stemrad, Ltd. From June 2009 until June 2020, Prof. Dekel served as Chief Scientist and a member of KidneyCure Inc. In 2011, Prof. Dekel Served as a Visiting Scholar at Stanford University. From January 2005, Prof. Dekel Served as a Fellow at the Weizmann Institute. Prof. Dekel holds an MD degree in Medicine from the Technion — Israel Institute of Technology and a PhD in Immunology & Transplantation Biology from the Weizmann Institute.
Assaf Itshayek has over 15 years of hi-tech industry experience in senior management and finance executive positions in different industries (including online, fintech and energy). Mr. Itshayek currently serves as a member of directors of GoTo Global Ltd., Qira Ltd. and Trinity Audio Ltd. From June 2021 until October 2022, Mr. Itshayek served as the chief executive officer of NeraTech Media Ltd. Prior thereto, from November 2012 until June 2021, Mr. Itshayek was at Somoto Ltd. (TASE: SMTO), initially as the chief financial officer and from December 2017, as the chief executive officer. Prior thereto, Mr. Itshayek served as the chief financial officer of BlueSnap Inc. (from February 2021) and Digital Power Corporation Ltd. (June 2009-May 2011) and served as the corporate controller of Metalink Ltd. from June 2006 until August 2008. From December 1999 until July 2006, Mr. Itshayek served as a TMT senior at Deloitte Brightman Almagor Zohar & Co., a Firm in the Deloitte Global Network. Mr. Itshayek holds a B.A. degree in Business Administration and Accountancy from the College of Management and an M.B.A. degree from Tel Aviv University.
| US \$ M | 9M/2023 9M/2022 Q3/2023 | Q3/2022 Details | |||
|---|---|---|---|---|---|
| PROPRIETARY | 86.4 | 67.2 | 31.4 | 25.6 | |
| DISTRIBUTION | 19.7 | 16.7 | 6.5 | 6.6 | |
| TOTAL REVENUES | 106.1 | 83.9 | 37.9 | 32.2 | 26% and 18% YoY increase for 9M & Q3, respectively |
| GROSS PROFIT | 41.1 | 31.4 | 14.8 | 12 9 | |
| GROSS MARGIN | 39% | 37% | 39% | 40% | |
| OPEX | (33.8) | (30.9) | (10.4) | (10.3) | |
| NET PROFIT | 3.2 | (5.3) | 3.2 | 0.5 | |
| Adjusted EBITDA | 17.7 | 10.6 | 7.9 | 6.0 | 67% and 31% YoY increase for 9M & Q3, respectively |
| CASH | 52.6 | 31.3 | |||
| TOTAL ASSETS | 337.1 | 3196 | Including acquisition related intangible assets (\$138M @ September 23) | ||
| BANK LOAN | 0.0 | 18.5 | 5-year term loan paid down in full during Q3-23 | ||
| CONTINGENT LIABILITIES | 72.1 | 85.7 | Acquisition related contingent consideration | ||
| EQUITY | 238.4 | 172.6 |


A global leader; focused on areas of limited treatment alternatives Financially stable; profitable; cash-generating; continued double digit growth 6 FDA approved products with significant worldwide growth potential Leading innovative product for AAT Deficiency in late stage development; Targeting a market of over \$1B
Significant upside potential with limited downside

November 2023
| US \$ M | 9M/2023 9M/2022 Q3/2023 | Q3/2022 | ||
|---|---|---|---|---|
| Net loss | 3.2 | (5.3) | 3.2 | 0.5 |
| Taxes on income | 0.2 | 0.1 | 0.1 | 0.0 |
| Revaluation of Acquisition related contingent consideration | 3.4 | 5.9 | 1.3 | 2.0 |
| Other financial expense, net | 0.5 | (0.2) | (0.2) | 0.0 |
| Amortization of acquisition related intangible assets | 5.3 | 5.3 | 1.8 | 1.8 |
| Other depreciation and amortization expenses | 4.2 | 3.9 | 1.4 | 1.3 |
| Non-cash share-based compensation expenses | 0.9 | 0 9 | 0.3 | 0.4 |
| Adjusted EBITDA | 17.7 | 10.6 | 7.9 | 6.0 |

| Page | |
|---|---|
| Condensed consolidated interim statements of financial position | 1 |
| Condensed consolidated interim statements of profit or loss and other comprehensive income | 2 |
| Condensed consolidated interim statements of changes in equity | 3-5 |
| Condensed consolidated interim statements of cash flows | 6-7 |
| Notes to the condensed consolidated interim financial statements | 8-15 |
| - - - - - - - - - - - |
| As of September 30, 2023 2022 Unaudited |
As of December 31, 2022 Audited |
|||||
|---|---|---|---|---|---|---|
| Assets | ||||||
| Current Assets | ||||||
| Cash and cash equivalents | \$ | 52,603 | \$ 31,252 |
\$ | 34,258 | |
| Trade receivables, net | 25,107 | 23,997 | 27,252 | |||
| Other accounts receivables | 1,648 | 6,884 | 8,710 | |||
| Inventories | 73,795 | 73,029 | 68,785 | |||
| Total Current Assets | 153,153 | 135,162 | 139,005 | |||
| Non-Current Assets | ||||||
| Property, plant and equipment, net | 27,362 | 25,898 | 26,157 | |||
| Right-of-use assets | 5,494 | 2,793 | 2,568 | |||
| Intangible assets, Goodwill and other long-term assets | 142,501 | 148,620 | 147,072 | |||
| Contract assets | 8,546 | 7,164 | 7,577 | |||
| Total Non-Current Assets | 183,903 | 184,475 | 183,374 | |||
| Total Assets | \$ | 337,056 | \$ 319,637 |
\$ | 322,379 | |
| Liabilities | ||||||
| Current Liabilities | ||||||
| Current maturities of bank loans | \$ | - | \$ 4,444 |
\$ | 4,444 | |
| Current maturities of lease liabilities | 1,138 | 1,004 | 1,016 | |||
| Current maturities of other long term liabilities | 15,989 | 25,095 | 29,708 | |||
| Trade payables | 12,812 | 30,619 | 32,917 | |||
| Other accounts payables | 7,318 | 7,948 | 7,585 | |||
| Deferred revenues | 15 | 40 | 35 | |||
| Total Current Liabilities | 37,272 | 69,150 | 75,705 | |||
| Non-Current Liabilities | ||||||
| Bank loans | - | 14,074 | 12,963 | |||
| Lease liabilities | 4,717 | 2,414 | 2,177 | |||
| Contingent consideration | 19,642 | 20,705 | 17,534 | |||
| Other long-term liabilities | 36,477 | 39,915 | 37,308 | |||
| Deferred revenues | - | 15 | - | |||
| Employee benefit liabilities, net | 558 | 813 | 672 | |||
| Total Non-Current Liabilities | 61,394 | 77,936 | 70,654 | |||
| Shareholder's Equity | ||||||
| Ordinary shares | 15,020 | 11,732 | 11,734 | |||
| Additional paid in capital net | 265,700 | 210,355 | 210,495 | |||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | |||
| Capital reserve from hedges | (98) | (257) | (88) | |||
| Capital reserve from share-based payments | 6,198 | 5,427 | 5,505 | |||
| Capital reserve from employee benefits | 318 | 212 | 348 | |||
| Accumulated deficit | (45,258) | (51,428) | (48,484) | |||
| Total Shareholder's Equity | 238,390 | 172,551 | 176,020 | |||
| Total Liabilities and Shareholder's Equity | \$ | 337,056 | \$ 319,637 |
\$ | 322,379 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
|||
|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | |
| Unaudited | Unaudited | Audited | |||
| Revenues from proprietary products | \$ 86,437 |
\$ 67,198 |
\$ 31,436 |
\$ 25,580 |
\$ 102,598 |
| Revenues from distribution | 19,650 | 16,702 | 6,498 | 6,637 | 26,741 |
| Total revenues | 106,087 | 83,900 | 37,934 | 32,217 | 129,339 |
| Cost of revenues from proprietary products | 47,863 | 37,856 | 17,447 | 13,151 | 58,229 |
| Cost of revenues from distribution | 17,146 | 14,632 | 5,684 | 6,196 | 24,407 |
| Total cost of revenues | 65,009 | 52,488 | 23,131 | 19,347 | 82,636 |
| Gross profit | 41,078 | 31,412 | 14,803 | 12,870 | 46,703 |
| Research and development expenses | 10,694 | 10,181 | 3,180 | 3,118 | 13,172 |
| Selling and marketing expenses | 11,573 | 10,435 | 3,711 | 3,843 | 15,284 |
| General and administrative expenses | 10,603 | 9,481 | 3,701 | 3,165 | 12,803 |
| Other expenses | 920 | 801 | (157) | 182 | 912 |
| Operating income (loss) | 7,288 | 514 | 4,368 | 2,562 | 4,532 |
| Financial income | 92 | 32 | 67 | 29 | 91 |
| Income (expenses) in respect of currency exchange differences and derivatives instruments, net |
726 | 756 | 553 | 163 | 298 |
| Financial Income (expense) in respect of contingent consideration and other long- term liabilities. |
(3,358) | (5,924) | (1,288) | (2,049) | (6,266) |
| Financial expenses | (1,343) | (583) | (404) | (211) | (914) |
| Income (expense) before tax on income | 3,405 | (5,205) | 3,296 | 494 | (2,259) |
| Taxes on income | 179 | 60 | 73 | 10 | 62 |
| Net income (loss) | \$ 3,226 |
\$ (5,265) |
\$ 3,223 |
\$ 484 |
\$ (2,321) |
| Other comprehensive income (loss) : Amounts that will be or that have been reclassified to profit or loss when specific conditions are met: |
|||||
| Gain (loss) on cash flow hedges | (334) | (830) | (90) | (46) | (776) |
| Net amounts transferred to the statement of profit or loss for cash flow hedges |
324 | 519 | 59 | 231 | 634 |
| Items that will not be reclassified to profit or loss in subsequent periods: |
|||||
| Remeasurement gain (loss) from defined benefit plan | (30) | 361 | (106) | (59) | 497 |
| Total comprehensive income (loss) | \$ 3,186 |
\$ (5,215) |
\$ 3,086 |
\$ 610 |
\$ (1,966) |
| Earnings per share attributable to equity holders of the Company: | |||||
| Basic net earnings per share | \$ 0.07 |
\$ (0.12) |
\$ 0.07 |
\$ 0.01 |
\$ (0.05) |
| Diluted net earnings per share | \$ 0.06 |
\$ (0.12) |
\$ 0.06 |
\$ 0.01 |
\$ (0.05) |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
| Share capital |
Additional paid in capital |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges Unaudited |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| In thousands | ||||||||||||||||
| Balance as of January 1, 2023 (audited) Net income |
\$ | 11,734 - |
\$ | 210,495 - |
\$ | (3,490) - |
\$ | (88) - |
\$ | 5,505 - |
\$ | 348 - |
\$ | (48,484) 3,226 |
\$ | 176,020 3,226 |
| Other comprehensive income (loss) | - | - | - | (10) | - | (30) | - | (40) | ||||||||
| Total comprehensive income (loss) | - | - | - | (10) | - | (30) | 3,226 | 3,186 | ||||||||
| Issuance of ordinary shares, net of issuance cost Exercise and forfeiture of share-based payment |
3,283 | 54,948 | - | - | - | - | - | 58,231 | ||||||||
| into shares | 3 | 257 | - | - | (257) | - | - | 3 | ||||||||
| Cost of share-based payment | - | - | - | - | 950 | - | - | 950 | ||||||||
| Balance as of September 30, 2023 | \$ | 15,020 | \$ | 265,700 | \$ | (3,490) | \$ | (98) | \$ | 6,198 | \$ | 318 | \$ | (45,258) | \$ | 238,390 |
| Additional Share paid in capital capital |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges |
Capital reserve from sharebased payments Unaudited |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
||||||||||
| In thousands | ||||||||||||||||
| Balance as of January 1, 2022 (audited) | \$ | 11,725 | \$ | 210,204 | \$ | (3,490) | \$ | 54 | \$ | 4,643 | \$ | (149) | \$ | (46,163) | \$ | 176,824 |
| Net income | - | - | - | - | - | - | (5,265) | (5,265) |
|---|---|---|---|---|---|---|---|---|
| Other comprehensive income (loss) | - | - | - | (311) | - | 361 | - | 50 |
| Total comprehensive income (loss) | - | - | - | (311) | - | 361 | (5,265) | (5,215) |
| Exercise and forfeiture of share-based payment | ||||||||
| into shares | 7 | 151 | - | - | (151) | - | - | 7 |
| Cost of share-based payment | - | - | - | - | 935 | - | - | 935 |
| Balance as of September 30, 2022 | \$ 11,732 |
\$ 210,355 |
\$ (3,490) |
\$ (257) |
\$ 5,427 |
\$ 212 |
\$ (51,428) |
\$ 172,551 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
| Share capital |
Additional paid in capital |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges |
Capital reserve from sharebased payments Unaudited |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| In thousands | |||||||||||||||
| Balance as of July 1, 2023 | \$ | 11,737 | \$ | 210,727 | \$ | (3,490) | \$ | (67) | \$ 5,902 |
\$ | 424 | \$ | (48,481) | \$ 176,752 |
|
| Net income | - | - | - | - | - | - | 3,223 | 3,223 | |||||||
| Other comprehensive income (loss) | - | - | - | 32 | - | (115) | - | (83) | |||||||
| Total comprehensive income (loss) | - | - | - | 32 | - | (115) | 1,812 | 1,729 | |||||||
| Issuance of ordinary shares, net of issuance cost | 3,283 | 54,948 | - | - | - | - | - | 58,231 | |||||||
| Exercise and forfeiture of share-based payment | |||||||||||||||
| into shares Cost of share-based payment |
- - |
25 - |
- - |
- - |
(25) 321 |
- - |
- - |
- 321 |
|||||||
| Balance as of September 30, 2023 | |||||||||||||||
| \$ | 15,020 | \$ | 265,700 | \$ | (3,490) | \$ | (98) | \$ 6,198 |
\$ | 318 | \$ | (45,258) | \$ 238,390 |
||
| Share capital |
Additional paid in capital |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges |
Capital reserve from sharebased payments Unaudited |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
||||||||
| In thousands | |||||||||||||||
| Balance as of July 1, 2022 | \$ | 11,731 | \$ | 210,319 | \$ | (3,490) | \$ | (442) | \$ | 5,097 | \$ | 271 | \$ | (51,912) | \$ 171,574 |
| Net income | - | - | - | - | - | - | 484 | 484 | |||||||
| Other comprehensive income (loss) | - | - | - | 185 | - | (59) | - | 126 | |||||||
| Total comprehensive income (loss) Exercise and forfeiture of share-based payment into shares |
- 1 |
- 36 |
- - |
185 - |
- (36) |
(59) - |
484 - |
610 1 |
|||||||
| Cost of share-based payment | - | - | - | - | 366 | - | - | 366 | |||||||
| Balance as of September 30, 2022 | \$ | 11,732 | \$ | 210,355 | \$ | (3,490) | \$ | (257) | \$ | 5,427 | \$ | 212 | \$ | (51,428) | \$ 172,551 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
| Share capital |
Additional paid in capital |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges Audited |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| In thousands | ||||||||||||||
| Balance as of January 1, 2022 (audited) | \$ 11,725 |
\$ | 210,204 | \$ | (3,490) | \$ | 54 | \$ | 4,643 | \$ | (149) | \$ | (46,163) | \$ 176,824 |
| Net income | - | - | - | - | - | - | (2,321) | (2,321) | ||||||
| Other comprehensive income (loss) | - | - | - | (142) | - | 497 | - | 355 | ||||||
| Total comprehensive income (loss) | - | - | - | (142) | - | 497 | (2,321) | (1,966) | ||||||
| Exercise and forfeiture of share-based payment | ||||||||||||||
| into shares | 9 | 291 | - | - | (291) | - | 9 | |||||||
| Cost of share-based payment | - | - | - | - | 1,153 | - | 1,153 | |||||||
| Balance as of December 31, 2022 | \$ 11,734 |
\$ | 210,495 | \$ | (3,490) | \$ | (88) | \$ | 5,505 | \$ | 348 | \$ | (48,484) | \$ 176,020 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
| Nine months period Ended September, 30 |
Three months period Ended September, 30 |
Year Ended December 31, |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | ||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars In thousands | ||||||||||||
| Cash Flows from Operating Activities | ||||||||||||
| Net income (loss) | \$ 3,226 |
\$ | (5,265) | \$ | 3,223 | \$ | 484 | \$ | (2,321) | |||
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
||||||||||||
| Adjustments to the profit or loss items: | ||||||||||||
| Depreciation and impairment | 9,506 | 9,143 | 3,179 | 3,055 | 12,155 | |||||||
| Financial expenses (income), net | 3,883 | 5,719 | 1,072 | 2,068 | 6,791 | |||||||
| Cost of share-based payment | 941 | 935 | 312 | 366 | 1,153 | |||||||
| Taxes on income | 179 | 60 | 73 | 10 | 62 | |||||||
| Loss (gain) from sale of property and equipment | (5) | - | - | - | - | |||||||
| Change in employee benefit liabilities, net | (144) | (106) | (104) | (10) | (111) | |||||||
| 14,360 | 15,751 | 4,532 | 5,489 | 20,050 | ||||||||
| Changes in asset and liability items: | ||||||||||||
| Decrease (increase) in trade receivables, net | 2,078 | 10,744 | (618) | (6,358) | 7,603 | |||||||
| Decrease (increase) in other accounts receivables | 2,716 | 2,917 | 1,177 | 844 | (578) | |||||||
| Decrease (increase) in inventories | (5,011) | (5,606) | 6,441 | (8,509) | (1,361) | |||||||
| Decrease (increase) in deferred expenses | 2,763 | (2,596) | (279) | (2,112) | (1,340) | |||||||
| Increase (decrease) in trade payables | (18,617) | 5,895 | (13,181) | 13,738 | 7,055 | |||||||
| Increase (decrease) in other accounts payables | (359) | 566 | 49 | 2,083 | 290 | |||||||
| Decrease in deferred revenues | (20) | - | (23) | - | (20) | |||||||
| (16,450) | 11,920 | (6,434) | (314) | 11,649 | ||||||||
| Cash received (paid) during the period for: | ||||||||||||
| Interest paid | (1,149) | (550) | (405) | (170) | (853) | |||||||
| Interest received | 92 | 15 | 67 | 12 | 97 | |||||||
| Taxes paid | (174) | (27) | (62) | (9) | (36) | |||||||
| (1,231) | (562) | (400) | (167) | (792) | ||||||||
| Net cash provided by (used in) operating activities | (95) \$ |
\$ | 21,844 | \$ | 921 | \$ | 5,492 | \$ | 28,586 |
| Nine months period Ended September, 30 |
Three months period Ended September, 30 |
Year Ended December 31, |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | |||||||
| Unaudited | Audited | ||||||||||
| U.S Dollars In thousands | |||||||||||
| Cash Flows from Investing Activities | |||||||||||
| Purchase of property and equipment and intangible assets | \$ | (3,876) | \$ | (2,807) | \$ | (1,729) | \$ | (1,616) | \$ | (3,784) | |
| Proceeds from sale of property and equipment | 6 | - | - | - | - | ||||||
| Net cash provided by (used in) investing activities | (3,870) | (2,807) | (1,729) | (1,616) | (3,784) | ||||||
| Cash Flows from Financing Activities | |||||||||||
| Proceeds from exercise of share base payments | 3 | 7 | - | 1 | 9 | ||||||
| Repayment of lease liabilities | (768) | (842) | (251) | (269) | (1,098) | ||||||
| Repayment of long-term loans | (17,407) | (1,517) | (15,185) | (1,116) | (2,628) | ||||||
| Repayment of other long-term liabilities | (17,500) | (4,120) | (11,500) | (877) | (5,626) | ||||||
| Proceeds from issuance of ordinary shares, net | 58,231 | - | 58,231 | - | - | ||||||
| Net cash provided by (used in) financing activities | 22,559 | (6,472) | 31,295 | (2,261) | (9,343) | ||||||
| Exchange differences on balances of cash and cash equivalent | (249) | 100 | 328 | (296) | 212 | ||||||
| Increase (decrease) in cash and cash equivalents | 18,345 | 12,665 | 30,815 | 1,319 | 15,671 | ||||||
| Cash and cash equivalents at the beginning of the period | 34,258 | 18,587 | 21,788 | 29,933 | 18,587 | ||||||
| Cash and cash equivalents at the end of the period | \$ | 52,603 | \$ | 31,252 | \$ | 52,603 | \$ | 31,252 | \$ | 34,258 | |
| Significant non-cash transactions | |||||||||||
| Right-of-use asset recognized with corresponding lease liability | \$ | 3,880 | \$ | 526 | \$ | 295 | \$ | 230 | \$ | 551 | |
| Purchase of property and equipment and Intangible assets | \$ | 681 | \$ | 134 | \$ | 681 | \$ | 134 | \$ | 618 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
Kamada Ltd. (the "Company") is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company's strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company's commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products CYTOGAM®, KEDRAB®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D) ® and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, Middle East and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years added eleven biosimilar products to its Israeli distribution portfolio, which, subject to European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D). In addition to the Company's commercial operation, it invests in research and development of new product candidates. The Company's leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial.
In November 2021, the Company acquired CYTOGAM, WINRHO SDF, VARIZIG and HEPGAM B from Saol Therapeutics Ltd. ("Saol"). The acquisition of this portfolio furthered the Company's core objective to become a fully integrated specialty plasma company with strong commercial capabilities in the U.S. market, as well as to expand to new markets, mainly in the Middle East/North Africa region, and to broaden the Company's portfolio offering in existing markets. The Company's wholly owned U.S. subsidiary, Kamada Inc., is responsible for the commercialization of the four products in the U.S. market, including direct sales to wholesalers and local distributers. Refer to Note 5 in our annual Financial report for further details on this acquisition.
a. Basis of preparation of the interim consolidated financial statements:
The interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, "Interim Financial Reporting".
b. Implementation of new accounting standards:
The Amendment, together with the subsequent amendment to IAS 1 (see hereunder) replaces certain requirements for classifying liabilities as current or noncurrent. According to the Amendment, a liability will be classified as non-current when the entity has the right to defer settlement for at least 12 months after the reporting period, and it "has substance" and is in existence at the end of the reporting period. According to the subsequent amendment, as published in October 2022, covenants with which the entity must comply after the reporting date do not affect classification of the liability as current or non-current. Additionally, the subsequent amendment adds disclosure requirements for liabilities subject to covenants within 12 months after the reporting date, such as disclosure regarding the nature of the covenants, the date they need to be complied with and facts and circumstances that indicate the entity may have difficulty complying with the covenants. Furthermore, the Amendment clarifies that the conversion option of a liability will affect its classification as current or noncurrent, other than when the conversion option is recognized as equity.
The Amendment and subsequent amendment are effective for reporting periods beginning on or after January 1, 2024 with earlier application being permitted. The Amendment and subsequent amendment are applicable retrospectively, including an amendment to comparative data.
The Company believes that the adoption of the Amendment will not have an effect on its financial statements.
The Company granted, out of the above mentioned, to employees and executive officers the following:
Under the Israeli Share Option Plan:
Under the US Appendix:
The Company granted, out of the above mentioned, to employees and executive officers the following:
Under the Israeli Share Option Plan:
Under the US Appendix:
On September 7, 2023, the Company closed a \$60 million private placement (the "Private Placement") with FIMI Opportunity Funds ("FIMI"), the leading private equity firm in Israel and a large existing shareholder of the Company. Under the terms of the Private Placement, the Company issued an aggregate of 12,631,579 ordinary shares to FIMI at a price of \$4.75 per share (which represented the average closing price of the Company's shares on NASDAQ during the 20 trading days prior to the date of execution of the Private Placement). Following the closing of the Private Placement, FIMI beneficially owns approximately 38% of the Company's outstanding ordinary shares and became a controlling shareholder of the Company, within the meaning of the Israeli Companies Law, 1999.
c. Bank Loan
On September 19, 2023, the Company paid down in full the outstanding balance of a \$20,000 thousand 5-year term loan borrowed during November 2021 from Bank Hapoalim, an Israeli bank.

a. General:
The company has two operating segments, as follows:
| Proprietary Products | - | Development, manufacturing, sales and distribution of proprietary plasma-derived protein therapeutics. |
|---|---|---|
Distribution - Distribute imported drug products in Israel, which are manufactured by third parties.
b. Reporting on operating segments:
| Proprietary Products |
Distribution U.S Dollars in thousands |
||||||
|---|---|---|---|---|---|---|---|
| Unaudited | |||||||
| Nine months period ended September 30, 2023 Revenues |
|||||||
| \$ 86,437 |
\$ 19,650 |
\$ | 106,087 | ||||
| Gross profit | \$ 38,574 |
\$ | 2,504 \$ |
41,078 | |||
| Unallocated corporate expenses | (33,790) | ||||||
| Finance expenses, net | (3,883) | ||||||
| Income before taxes on income | \$ | 3,405 |
| Proprietary | ||||||
|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Nine months period ended September 30, 2022 | ||||||
| Revenues | \$ 67,198 |
\$ | 16,702 | \$ | 83,900 | |
| Gross profit | \$ 29,342 |
\$ | 2,070 | \$ | 31,412 | |
| Unallocated corporate expenses | (30,898) | |||||
| Finance expenses, net | (5,719) | |||||
| Income before taxes on income | \$ | (5,205) |
| Proprietary | |||||||
|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Three months period ended September 30, 2023 | |||||||
| Revenues | \$ | 31,436 | \$ | 6,498 | \$ | 37,934 | |
| Gross profit | \$ | 13,989 | \$ | 814 | \$ | 14,803 | |
| Unallocated corporate expenses | (10,435) | ||||||
| Finance expenses, net | (1,072) | ||||||
| Income before taxes on income | \$ | 3,296 |
| Proprietary | ||||||
|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Three months period ended September 30, 2022 | ||||||
| Revenues | \$ | 25,580 | \$ | 6,637 | \$ | 32,217 |
| Gross profit | \$ | 12,429 | \$ | 441 | \$ | 12,870 |
| Unallocated corporate expenses | (10,308) | |||||
| Finance expenses, net | (2,068) | |||||
| Income before taxes on income | \$ | 494 |
b. Reporting on operating segments:
| Proprietary | |||||||
|---|---|---|---|---|---|---|---|
| Products Distribution |
Total | ||||||
| U.S Dollars in thousands | |||||||
| Audited | |||||||
| Year Ended December 31, 2022 | |||||||
| Revenues | \$ | 102,598 \$ |
26,741 | \$ | 129,339 | ||
| Gross profit | \$ | 44,369 \$ |
2,334 | \$ | 46,703 | ||
| Unallocated corporate expenses | (42,171) | ||||||
| Finance expenses, net | (6,791) | ||||||
| Income before taxes on income | \$ | (2,259) |
c. Reporting on operating segments by geographic region:
| Nine months period ended September 30, 2023 |
|||||||
|---|---|---|---|---|---|---|---|
| Proprietary Products Distribution U.S Dollars in thousands |
Total | ||||||
| Unaudited | |||||||
| Geographical markets | |||||||
| U.S.A and North America | \$ | 62,150 | \$ | - | \$ | 62,150 | |
| Israel | 3,119 | 19,650 | 22,769 | ||||
| Europe | 6,724 | - | 6,724 | ||||
| Latin America | 10,365 | - | 10,365 | ||||
| Asia | 3,958 | - | 3,958 | ||||
| Others | 121 | - | 121 | ||||
| \$ | 86,437 | \$ | 19,650 | \$ | 106,087 |
Three months period ended
c. Reporting on operating segments by geographic region:
| Nine months period ended September 30, 2022 |
||||||
|---|---|---|---|---|---|---|
| Proprietary | ||||||
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A and North America. | \$ 52,866 |
\$ - |
\$ | 52,866 | ||
| Israel | 3,631 | 16,702 | 20,333 | |||
| Europe | 2,192 | - | 2,192 | |||
| Latin America | 5,301 | - | 5,301 | |||
| Asia | 2,665 | - | 2,665 | |||
| Others | 543 | - | 543 | |||
| \$ 67,198 |
\$ 16,702 |
\$ | 83,900 |
| Three months period ended September 30, 2023 |
|||||||
|---|---|---|---|---|---|---|---|
| Proprietary Products Distribution |
Total | ||||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Geographical markets | |||||||
| U.S.A and North America. | \$ | 25,294 | \$ | - | \$ | 25,294 | |
| Israel | 1,017 | 6,498 | 7,515 | ||||
| Europe | 3,280 | - | 3,280 | ||||
| Latin America | 328 | - | 328 | ||||
| Asia | 1,479 | - | 1,479 | ||||
| Others | 38 | - | 38 | ||||
| \$ | 31,436 | \$ | 6,498 | \$ | 37,934 |
| September 30, 2022 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Proprietary Products Distribution |
Total | ||||||||
| U.S Dollars in thousands | |||||||||
| Unaudited | |||||||||
| Geographical markets | |||||||||
| U.S.A and North America. | \$ | 20,597 | \$ | - | \$ | 20,597 | |||
| Israel | 1,377 | 6,637 | 8,014 | ||||||
| Europe | 750 | - | 750 | ||||||
| Latin America | 1,775 | - | 1,775 | ||||||
| Asia | 767 | - | 767 | ||||||
| Others | 314 | - | 314 | ||||||
| \$ | 25,580 | \$ | 6,637 | \$ | 32,217 |
| Year ended December 31, 2022 | ||||||
|---|---|---|---|---|---|---|
| Proprietary | ||||||
| Products Distribution |
Total | |||||
| U.S Dollars in thousands | ||||||
| Audited | ||||||
| Geographical markets | ||||||
| U.S.A and North America | \$ 75,851 |
\$ | - | \$ | 75,851 | |
| Israel | 5,290 | 26,741 | 32,031 | |||
| Europe | 5,277 | - | 5,277 | |||
| Latin America | 11,294 | - | 11,294 | |||
| Asia | 4,581 | - | 4,581 | |||
| Others | 305 | - | 305 | |||
| \$ 102,598 |
\$ | 26,741 | \$ | 129,339 |
a. Classification of financial instruments by fair value hierarchy
| Level 1 | Level 2 | Level 3 | |||
|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||
| September 30, 2023 | |||||
| Derivatives instruments | \$ | - | \$ | (98) | \$ - |
| Contingent consideration | - | - | (22,326) | ||
| September 30, 2022 | |||||
| Derivatives instruments | (180) | ||||
| Contingent consideration | \$ | - | \$ | (23,705) \$ |
|
| December 31, 2022 | |||||
| Derivatives instruments | \$ | - | \$ | (92) | \$ - |
| Contingent consideration | |||||
| \$ | - | \$ | - | (23,534) \$ |
During the nine months ended on September 30, 2023 there were no transfers due to the fair value measurement of any financial instrument from Level 1 to Level 2, and furthermore, there were no transfers to or from Level 3 due to the fair value measurement of any financial instrument.
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